QM Associate - Regulatory Affairs

  • Full-time
  • Department: Quality Management

Company Description

Dr. Langer Medical GmbH, based in Waldkirch, which has been part of Brainlab AG in Munich since 2022, has specialized in the development and marketing of highly innovative medical technology for intraoperative neuromonitoring and neurostimulation for more than 25 years. Our products are groundbreaking in design and handling and form the basis for our worldwide growth. It is therefore no coincidence that the products from Dr. Langer Medical as well as the company itself have been honored several times in the past with various prizes and awards. You can look forward to a friendly and highly motivated team. Your future starts now.

Job Description

You are interested in Regulatory Affairs or in the development of medical devices? As QM Associate in our Regulatory Affairs team you will interact with Dr. Langer Medical departments and partners internationally and Regulatory Agencies from all over the world. In a cross-functional team you will be involved in the development of various Dr. Langer Medical products and be responsible for establishing the regulatory strategy. You will interpret regulatory requirements and implement them in projects.

Your duties include:

  • Collaboration on the creation, updating and review of the Technical documentation before CE marking a new/changed medical device
  • Evaluate and follow up design changes during the development and implementation
  • Participation in the documentation of product changes - change management
  • Discuss regulatory topics with R&D colleagues and other departments
  • Establish global regulatory strategies for Dr. Langer Medical  medical devices in collaboration with local partners of the Brainlab subsidiaries
  • Compile regulatory submissions to be send to authorities e.g. 510(k) submissions to FDA, the Notified Body and other authorities
  • Monitor & investigate regulatory requirements in pre-defined countries
  • Partitipation and preparation of regulatory audits and follow up improvement opportunities
  • Regular market monitoring and preparation of PMS/PSU reports
  • Train Dr. Langer Medical employees in regulatory requirements


  • Degree in engineering or life sciences preferred, but other degrees may be considered
  • Professional experience in regulatory affairs or regulatory compliance in the medical device field. Previous experience in other departments related to the development of a medical device is a plus (e.g. in R&D)
  • Excellent English and proficient German written and verbal communication skills
  • Ability to communicate with all stakeholders
  • Independent, structured and pragmatic working style
  • Persuasive power

Additional Information

  • A mutually supportive and international team
  • Meaningful activities with a lasting impact on medical technology
  • TOP 100 innovator and employer of the future 2022
  • Very good opportunities for further training and career development within Brainlab AG
  • Modern working environment with flexible working hours
  • Internal company fitness program

Ready to apply? We look forward to receiving your online application including your first available start date and desired salary. 

Contact person: Daniel Sypli

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